Incidence and Severity Associated With Adverse Drug Reactions in Surgery Inpatients

Aim: Present study was carried out to assess the incidence of adverse drug reactions (ADR) and assessment of causality and severity associated with reported suspected ADRs. Materials and Methods: A prospective cross sectional spontaneous reporting study was conducted over a period of six months in inpatients of Surgery wards of Prince bijaysingh memorial (PBM)Hospital ,Bikaner Rajasthan. Naranjo Probability scale was used for causality assessment. Reported ADRs were classified according to Rawlin and Thomson classification and assessed for severity using scale developed by Hartwig et al. Results: A total of 45 suspected Adverse Drug Reactions report forms were reported during the period of 6 months of study in 3565 admitted patients in general surgery wards showing an overall incidence of 1.26%. Gastrointestinal system (51.7%) was most commonly involved. Drug class most commonly associated was Antimicrobials(80.2%). 95.6% of ADRs were classified as “Possible” in view of causality, while 91.2% were found to be “mild” in case of severity. Most patients recovered (66.7%) from the ADR’s. 73.3% ADR’s were augmented or type A. Conclusion: Awareness about ADR reporting is still poor amongst healthcare professionals in India. The incidence and severity of ADRs documented in our study are lower than those reported in other studies. Antibiotics comprise the major drug family associated with ADRs so should be rationally prescribed . Improved communication between the physicians and nurses with the pharmacovigilance centre in the hospital is suggested.